Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions,
New England Life Care, Inc. dba Advanced Compounding Solutions
Summary
The FDA issued a Class III for Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compou by New England Life Care, Inc. dba Advanced Compounding Solutions. Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride.
Details
Source
Drug Recall
External ID
D-0778-2023
Action Date
2023-06-07
Status
Terminated
Category
drug
Product Description
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Lot/Code Info: Lot # 20230323-728BF8, exp. 08/20/2023
Quantity Affected: 198
Reason for Recall
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-22
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 243 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
New England Life Care, Inc. dba Advanced Compounding Solutions has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New England Life Care, Inc. dba Advanced Compounding Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New England Life Care, Inc. dba Advanced Compounding Solutions have FDA actions?
New England Life Care, Inc. dba Advanced Compounding Solutions has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0778-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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